400636E

GUDID H980400636E0

1.3MM TI MF CORTEX SCREW SELF-TAPPING WITH FLUTES 16MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH980400636E0
NIH Device Record Keyefd3680e-a07d-4565-b574-84ad39b7f069
Commercial Distribution StatusIn Commercial Distribution
Version Model Number400.636E
Catalog Number400636E
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587044590 [Primary]
HIBCCH980400636E0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


[H980400636E0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-14

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H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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